Urinary IncontinenceMBSR-YogaNCT01470560
Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Urinary Incontinence and Urinary Incontinence, Urge, run by University of Utah at 1 site in United States.
Trial summary
Many women experience the accidental loss of urine called urge incontinence or overactive bladder (OAB) incontinence. Women describe this as a sudden, strong desire to pass urine which results in leakage before reaching the toilet. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Urge
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females at least 18 years of age
- Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
- Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
- Request for treatment for urge urinary incontinence.
- Subject is able to complete all study related items and interviews.
Who cannot join
- Any current or recent (past 4 weeks) anticholinergic medication use. Patient may discontinue medication and after 4 weeks may be eligible for study.
- Past non-pharmacologic treatment for urge incontinence such as supervised behavioral therapy, supervised or unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
- Current symptomatic urinary tract infection that has not resolved prior start of MBSR group.
- Symptoms of pelvic organ prolapse screened by PFDI (Pelvic Floor Disorder Inventory question #3) "Do you have a bulge or something falling out that you can see or feel in the vaginal area?"
- Previous or currently implanted neuromodulation (sacral or tibial).
- Surgically altered detrusor muscle, such as augmentation cystoplasty.
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- Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
- In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.
- Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
- Currently pregnant or within 6 months postpartum (pregnancy is not excluded for safety reasons but for quality of data)
Trial locations and contacts
1 site in 1 country.
About this study
Many women experience the accidental loss of urine called urge incontinence or overactive bladder (OAB) incontinence. Women describe this as a sudden, strong desire to pass urine which results in leakage before reaching the toilet. The current usual treatments for urge incontinence include behavioral treatment, physical therapy, and medicines. Although these treatments have been found to be effective in research studies, they are less effective over time in general practice. Because medicines have side effects, many women stop them. The purpose of this study is to explore different treatments that may provide another option for women with urge incontinence that might be effective. This is an initial study to see if these treatments are at least as effective as the usual treatments.
Hypothesis: Does Mind Based Stress Reduction(MBSR)(meditation practices)reduce urinary urge incontinence episodes?
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge
- Being tested
- Mindfulness-Based Stress Reduction (MBSR), Sham Yoga Group
- Keywords
- Mindfulness, Mindfulness-Based Stress Reduction, Meditation, Yoga
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
Also called MBSR developed by Jon Kabat-Zinn
Mindfulness-Based Stress Reduction (MBSR) was developed by Jon Kabat-Zinn in 1979. MBSR is a group-based intervention, typically provided to up to 30 participants, in a class-based format of eight weekly two hour sessions.
Sham Yoga GroupBehavioural
Emphasis will be placed on healthy alignment and ways to pace and adjust poses to make them safe and productive for the body.
| Study group | Role | What they receive |
|---|---|---|
| Sham Yoga Group Treatment | Sham comparator | Sham yoga group (control group) will attend 8 weekly sessions for 1-2 hours and will be lead by a certified yoga instructor. The yoga class will be based on Pantajali's Eight Fold Path which is the basis of Yoga. Emphasis will be placed on healthy alignment and ways to pace and adjust poses to make them safe and productive for the body. Receives: Behavioral: Sham Yoga Group |
| MBSR Group Treatment | Active comparator | Mindfulness-Based Stress Reduction (MBSR) was developed by Jon Kabat-Zinn in 1979. MBSR is a group-based intervention, typically provided to up to 30 participants, in a class-based format of eight weekly two hour sessions. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Post Leakage Episodes
The primary outcome for the study is the change from baseline in mean number of urge incontinent episodes from pre treatment to post-treatment measured using 3-day voiding diaries.
Measured: 0 (Baseline) and 8 weeks
Secondary outcomes (1)
Quality of Life
Secondary Outcome Measures are a change from baseline in the Overactive Bladder Questionnaire (OABq-SF) scores and proportion of subjects reporting improvement from the Patient Global Impression of Improvement (PGI-I)).
Measured: 0 (Baseline) and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Baker, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470560
- Sponsor's protocol ID
- IRB00047159
- Acronym
- MBSR-Yoga
- Status last verified
- Dec 2014
- First submitted
- 9 Nov 2011
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)
- ClinicalTrials.gov ID
- NCT01470560
- Acronym / sponsor ID
- MBSR-Yoga / IRB00047159
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge
- Keywords
- Mindfulness, Mindfulness-Based Stress Reduction, Meditation, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many women experience the accidental loss of urine called urge incontinence or overactive bladder (OAB) incontinence. Women describe this as a sudden, strong desire to pass urine which results in leakage before reaching the toilet. The current usual treatments for urge incontinence include behavioral treatment, physical therapy, and medicines. Although these treatments have been found to be effective in research studies, they are less effective over time in general practice. Because medicines have side effects, many women stop them. The purpose of this study is to explore different treatments that may provide another option for women with urge incontinence that might be effective. This is an initial study to see if these treatments are at least as effective as the usual treatments.
Hypothesis: Does Mind Based Stress Reduction(MBSR)(meditation practices)reduce urinary urge incontinence episodes?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Yoga Group Treatment | Sham comparator | Behavioral: Sham Yoga GroupSham yoga group (control group) will attend 8 weekly sessions for 1-2 hours and will be lead by a certified yoga instructor. The yoga class will be based on Pantajali's Eight Fold Path which is the basis of Yoga. Emphasis will be placed on healthy alignment and ways to pace and adjust poses to make them safe and productive for the body. |
| MBSR Group Treatment | Active comparator | Behavioral: Mindfulness-Based Stress Reduction (MBSR)Mindfulness-Based Stress Reduction (MBSR) was developed by Jon Kabat-Zinn in 1979. MBSR is a group-based intervention, typically provided to up to 30 participants, in a class-based format of eight weekly two hour sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females at least 18 years of age
- Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
- Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
- Request for treatment for urge urinary incontinence.
- Subject is able to complete all study related items and interviews.
Key exclusion criteria (10 listed)
- Any current or recent (past 4 weeks) anticholinergic medication use. Patient may discontinue medication and after 4 weeks may be eligible for study.
- Past non-pharmacologic treatment for urge incontinence such as supervised behavioral therapy, supervised or unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
- Current symptomatic urinary tract infection that has not resolved prior start of MBSR group.
- Symptoms of pelvic organ prolapse screened by PFDI (Pelvic Floor Disorder Inventory question #3) "Do you have a bulge or something falling out that you can see or feel in the vaginal area?"
- Previous or currently implanted neuromodulation (sacral or tibial).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR)Also: MBSR developed by Jon Kabat-ZinnMindfulness-Based Stress Reduction (MBSR) was developed by Jon Kabat-Zinn in 1979. MBSR is a group-based intervention, typically provided to up to 30 participants, in a class-based format of eight weekly two hour sessions. | Behavioural | MBSR Group Treatment |
| Sham Yoga GroupEmphasis will be placed on healthy alignment and ways to pace and adjust poses to make them safe and productive for the body. | Behavioural | Sham Yoga Group Treatment |
Primary outcome
Pre-Post Leakage Episodes
Time frame: 0 (Baseline) and 8 weeks
The primary outcome for the study is the change from baseline in mean number of urge incontinent episodes from pre treatment to post-treatment measured using 3-day voiding diaries.
1 secondary outcome
Quality of Life
Time frame: 0 (Baseline) and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Urinary Incontinence and Urinary Incontinence, Urge, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Post Leakage Episodes (time frame: 0 (Baseline) and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.